The use of splints and other reinforcing materials to maintain the position of tissues following surgery is a common technique in medicine. These structures are often secured in position using a suture tied to the surrounding tissue or tissues. Thin gauge suture material is used to minimize scarring and disruption to the anchoring tissue. While successful in doing so, the use of small-diameter suture material can introduce some difficulties when the splints are to be removed during the course of a patient's recovery. Thin suture material can be difficult to identify and isolate at the healing surgical site, leading to a potentially painful and cumbersome excavation procedure (patients are awake at the follow-up visits when the splints or reinforcing materials are removed). The devices and methods describe herein may simplify the identification and cutting of suture materials used to fix splints, stents, reinforcing materials, and the like in position at a surgical site.
As an example, septoplasty, or the surgical correction of problems of the nasal septum, is a procedure commonly performed to address a number of issues that can affect the quality of a patient's life. For example, the procedure may involve repairing a defect to the septum that is partially or fully occluding the airways in the nose (e.g., a deviated septum, in which the nasal septum does not equally divide the nasal cavity into two halves), uncontrollable nosebleeds, and to repair a hole in the nasal septum (i.e., a nasal perforation).
To perform a septoplasty, a surgeon generally makes an incision on one side of the nasal septum, lift the mucus membrane that covers the septum off of the cartilage and/or bone of the nasal septum, remove, modify, or move the structures of the nasal septum that are causing the patient's symptoms, and replace the mucus membrane over the surgically-altered structure of the nasal septum. The membrane may be held in place using sutures, splints, packing materials, or a combination thereof.
The maintenance of a midline orientation of the septum (dividing the nasal cavity into two approximately equal halves) is the prime goal following septoplasty. Nasal splints are commonly used to achieve this end. The placement of a splint on each side of the septum keeps it aligned during the critical healing period immediately following surgery. These splints are typically shaped and sized to support the septum and provide a clear airway during the recovery period, and are supplied in pairs (each individual unit configured for placement on the right or left side of the nasal septum). Splints of this nature are typically sutured to the nasal septum through the proximal end of the splints. One suture is used to bind both splints to the nasal septum; this is done by passing a suture needle through one splint, starting from the face situated away from the septum, through the septum, through the second splint on the other side of the septum, and back through the septum proximal to the splints. The two free ends of the suture are then tied off to maintain the position of the splints with respect to the nasal septum, while the size and structure of the splints maintain the position of the nasal septum with respect to the nasal cavity.
A common commercially available nasal splint is the Doyle splint. The basic design of the Doyle splint is disclosed in U.S. Pat. No. 3,935,859 and remains one of the most used nasal splints following septoplasty. The Doyle splint includes a flat plate contoured to accommodate the nasal septum and an integral tube running the length of the flat plate opposite to the side of the plate that would rest against the nasal septum. The top edge of the plate has a convex curve and the bottom edge of the plate is slightly concave. The anterior and posterior ends of the plate are rounded to provide ease of insertion and patient comfort. The tube extends almost the full length of the splint and provides a passageway for airflow.
The anterior ends of a pair of Doyle splints are typically sutured to the nasal septum after placement against the surgically repaired nasal septum (one splint on each side of the septum). Once the position of the Doyle splints has been secured with the suture, the spaces surrounding the splint are sometimes packed with gauze or other materials to fully support the septum. The presence of the tube allows the patient to breath while the packing material is resident.
Variations of the Doyle splint include the Breeze Nasal Airway Splint (Summit Medical), the Nasal Airway Splint, Doyle Open Lumen Splint, Doyle Combo Splint (Boston Medical Products), and the Doyle Bi-Valve Airway Splint (Medtronic), which add or change features of the original Doyle splint, but all are sutured into position in a similar fashion after placement. Other nasal splint designs exist that eliminate the tube feature of the Doyle-style splints, add pre-formed holes intended to facilitate placement of the suture, and/or change the geometry of the flat plate, but these too require fixation with a suture after the splint is placed in the patient.
The use of a suture to secure the position of existing splints may cause difficulties when the splints are removed at a post-surgical follow-up exam. At a typical follow up visit, the surgeon cuts the suture holding or securing the splints against the septum. This procedure can be difficult to perform while the patient is awake as the post-surgical mucosal surfaces of the nasal cavity may be very sensitive to touch. Patients often move while the surgeon is attempting to locate and cut/release the suture. The procedure is further complicated by the tight apposition of the splint to the septum. Finding the suture can be difficult due to the small diameter or gage of the suture material that is typically used in these procedures (e.g., 3-0 silk) and the presence of encrustations of dried mucus and blood that can cover and obscure the suture site. Once found, positioning the surgical scissors to cut the suture without harming or causing discomfort to the patient can be a difficult and time-consuming task.
While existing nasal splints serve the purpose of supporting the septum and maintaining an open airway to the nasal cavity, there is a need for an intranasal splint that facilitates locating and cutting a stabilizing suture at the time of removal.